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Completed

NCT Number: NCT01085929

Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses

The incidence of skin and soft tissue infections has increased dramatically over the last decade, in part due to increased prevalence of community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). Incision and drainage (I&D) is considered the primary intervention, however some clinicians prefer ultrasound guided needle aspiration (US Asp). The investigators performed a randomized trial comparing US Asp to I&D for uncomplicated skin and soft tissue abscesses, with a subgroup analysis of patients with CA-MRSA.

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Key information

Conditions

Abscess Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beth Isreal Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • presenting to emergency department with skin abscess
  • abscess required surgical drainage
  • healthy appearing

Exclusion criteria

  • pregnant
  • unable to give consent
  • abscess located in oral cavity
  • abscess located on genitalia
  • abscess located intra-gluteal at coccyx

Treatment and study plan

Incision and Drainage

Procedure

Surgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity.

Ultrasound Guided Aspiration

Procedure

Ultrasound is used to identify the abscess cavity. An 18 gauge needle is introduced into the abscess cavity and manual aspiration of the abscess contents is attempted.

Primary outcomes

  1. Successful drainage of abscess

    Time frame: 7 days

    Clinical outcome at 7 days

Secondary outcomes

  1. Successful drainage of abscess

    Time frame: 2 days

    Healing of abscess following drainage procedure at day 2

  2. Ability to evacuate purulence from abscess

    Time frame: Day 1

    Amount of purulence produced by drainage procedure on day 1

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study title

Ultrasound Guided Needle Drainage Versus Formal Incision and Drainage of Superficial Soft Tissue Abscesses in the Emergency Department Setting

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 12, 2010
Registry last updated
Mar 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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